Peripheral Nerve Injury, Virtual Reality, RehabilitationNCT05898568
Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
A study testing virtual reality and routine treatment in people with Peripheral Nerve Injury, Virtual Reality, Rehabilitation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injury, Virtual Reality, Rehabilitation
- What is being tested?
- virtual reality and routine treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ıt was operated in the early period with the diagnosis of peripheral nerve injury in the postoperative hand.
- clinical impression was made.
- out patient with median, ulnar, and radial nerve repair.
- completed the 6th postoperative week.
Who cannot join
- Those who have communication problems and users
- With the musculoskeletal system, the additional passage, rheumatological, etc., where they are located.
- those with the disease
- Patients with multiple traumas
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand.
- Being tested
- virtual reality, routine treatment
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
In addition to the routine hand rehabilitation programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days a week, 20 minutes) virtual reality based movement therapy program will be applied.
routine treatmentBehavioural
20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied.
| Study group | Role | What they receive |
|---|---|---|
| experimental: virtual reality | Experimental | In addition to routine hand care programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days, 20 minutes) virtual reality based movement therapy program will be applied. Receives: Device: virtual reality |
| control:routine treatment | Active comparator | 20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be implemented. Receives: Behavioral: routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen Taylor Hand Function Test
Used to assess upper extremity functions. Activities are evaluated on a time basis.
Measured: from baseline to the end of the treatment (4 week)
visual analog scale (VAS)
marks the severity of pain between 0 and 10.
Measured: from baseline to the end of the treatment (4 week)
duruöz hand index
kitchen work, evaluates cleaning, workplace and other activities of daily living. The total score is between 0-90.
Measured: from baseline to the end of the treatment (4 week)
Sammes Weinstein Monofilament Test (SWMT)
sensory threshold is used for assessment.sensed monofilament values will be collected and recorded. The highest total score will be considered as 15.
Measured: from baseline to the end of the treatment (4 week)
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)
activity participation level will be assessed by Q-DASH.Each question will be scored between 1-5 points (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: not at all). The total score will be recorded.
Measured: from baseline to the end of the treatment (4 week)
Jamar dynamometer
Jamar dynamometer will be used for grip strength. 3 repetitive measurements will be made and the average will be recorded.(in kilograms)
Measured: from baseline to the end of the treatment (4 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Apr 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Injury, Virtual Reality, RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Kablanoğlu, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898568
- Sponsor's protocol ID
- E-66175679-514.13.02-960185
- Status last verified
- Jan 2024
- First submitted
- 2 Jun 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
- ClinicalTrials.gov ID
- NCT05898568
- Acronym / sponsor ID
- E-66175679-514.13.02-960185
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental: virtual reality | Experimental | Device: virtual realityIn addition to routine hand care programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days, 20 minutes) virtual reality based movement therapy program will be applied. |
| control:routine treatment | Active comparator | Behavioral: routine treatment20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be implemented. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ıt was operated in the early period with the diagnosis of peripheral nerve injury in the postoperative hand.
- clinical impression was made.
- out patient with median, ulnar, and radial nerve repair.
- completed the 6th postoperative week.
Key exclusion criteria (4 listed)
- Those who have communication problems and users
- With the musculoskeletal system, the additional passage, rheumatological, etc., where they are located.
- those with the disease
- Patients with multiple traumas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual realityIn addition to the routine hand rehabilitation programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days a week, 20 minutes) virtual reality based movement therapy program will be applied. | Device | experimental: virtual reality |
| routine treatment20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied. | Behavioural | control:routine treatment |
Primary outcome
Jebsen Taylor Hand Function Test
Time frame: from baseline to the end of the treatment (4 week)
Used to assess upper extremity functions. Activities are evaluated on a time basis.
visual analog scale (VAS)
Time frame: from baseline to the end of the treatment (4 week)
marks the severity of pain between 0 and 10.
duruöz hand index
Time frame: from baseline to the end of the treatment (4 week)
kitchen work, evaluates cleaning, workplace and other activities of daily living. The total score is between 0-90.
Sammes Weinstein Monofilament Test (SWMT)
Time frame: from baseline to the end of the treatment (4 week)
sensory threshold is used for assessment.sensed monofilament values will be collected and recorded. The highest total score will be considered as 15.
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)
Time frame: from baseline to the end of the treatment (4 week)
activity participation level will be assessed by Q-DASH.Each question will be scored between 1-5 points (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: not at all). The total score will be recorded.
Jamar dynamometer
Time frame: from baseline to the end of the treatment (4 week)
Jamar dynamometer will be used for grip strength. 3 repetitive measurements will be made and the average will be recorded.(in kilograms)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality and routine treatment in people with Peripheral Nerve Injury, Virtual Reality, Rehabilitation, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebsen Taylor Hand Function Test (time frame: from baseline to the end of the treatment (4 week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.